Stöckert 3T Heater-Cooler Devices
Patients in the Pittsburgh and surrounding Ohio Valley areas who had open-heart surgery and then suffered a serious infection may be eligible to recover medical costs and other damages in a personal injury lawsuit.
Sorin Group USA, Inc. and LivaNova Deutschland GmbH (collectively “manufacturer”), recently revealed that their 3T Heater-Cooler Units (HCUs)—which are frequently used during open-heart surgeries —may be the source of nontuberculous mycobacterium (NTM) infections. These infections can cause serious illness and even death.
We are now learning that some devices used open-heart surgeries were contaminated with Mycobacterium chimaera (M. chimaera), a type of NTM, at the manufacturing site. When the devices were then used in surgery in hospitals around the U.S., airborne bacteria could have been spread throughout the operating room, and infected patients undergoing open-heart surgeries through their open surgical wounds.
According to The Washington Post, in just the past year, at least 28 cases of M. chimaera infections have been identified at hospitals in Iowa, Michigan, and Pennsylvania. More have been reported in patients in Europe and in other parts of the U.S.
On October 13, 2016, the Food and Drug Administration (FDA) released a safety communication warning that surgery with these devices had been linked with M. chimaera infections. They advised doctors and hospitals to immediately remove any of these devices that test positive for the bacteria from their facilities and to consider limiting the use of these devices until the manufacturer finds a way to mitigate the risks of patient infection.
Heater-Cooler Units Increase Risk of Infections
The New York Times recently reported that, in 2015, at least twelve patients at a Pennsylvania hospital were infected by an HCU used during their open-heart surgeries. A field investigation by the Pennsylvania Department of Health, with help from the Centers for Disease Control and Prevention (CDC), determined that there was an association between the M. chimaera infections and exposure to contaminated Stöckert 3T HCDs.
Once they figured this out, the hospital notified 1,300 patients who may have been exposed to the HCU in surgery of the potential risk of infection.
Other patient infections have been reported in Iowa. There, investigators conducted laboratory tests, including whole genome sequencing on isolates from eleven patients, and three tests on five HCU devices. The HCUs were tested by taking:
- swabs from the interior of the device;
- samples of water drained from the devices; and
- air samples collected while a device was operating.
These tests found that the Stöckert 3T HCDs were contaminated with M. chimaera. Investigators noted that a recent report from Germany indicated that M. chimaera samples taken from HCDs from three different European countries were almost identical to samples obtained from the manufacturing site.
The CDC has reported that, although thousands of patients who may have been exposed to the bacteria in the U.S. have already been notified, the actual number at risk may be much higher. Over 250,000 cardiopulmonary bypass procedures (such as open-heart surgery) are performed each year in the U.S., and Stöckert 3T HCDs represent about 60 percent of the devices used in these surgeries.
What are Heater-Cooler Units?
HCUs are medical devices that help regulate patients body temperature during open heart surgery. Procedures in which they are used include open-heart surgery, coronary artery bypass surgery, heart valve surgery, and lung transplant surgery.
These devices have water tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits. Though the water never comes into contact with the patient, the devices have fans and exhaust vents.
Contaminated water from inside the device can aerosolize as it travels through the closed circuits. That contaminated air can then be pushed into the operating room through the exhaust vents where it can contaminate the patient undergoing cardiothoracic surgery.
In September 2016, the Seattle Times reported that bacteria that cause Legionnaires’ disease (which is a serious form of pneumonia) had been detected in HCUs used during open-heart surgeries. Three of the machines tested positive for the bacteria. And at least four patients were diagnosed with the disease, two of whom died following surgery.
In our daily lives, we are exposed to many types of bacteria that usually don’t affect us because our immune system is effective at fighting them off. They can be particularly dangerous during open-heart surgery, however, because patients are in a particularly vulnerable state because their inner organs are exposed to the air. They may also have weakened or compromised immune systems.
Adding to the danger is that once the machines are contaminated, it is difficult to make them safe again. HCUs can be hard to clean because bacteria can form a biofilm on the machine that is resistant to typical disinfectants and sterilization procedures.
What are Stöckert 3T Heater-Cooler Units?
Currently, there are about 2,000 Stöckert 3T HCDs in the U.S. They are manufactured by Sorin Group USA, Inc. and LivaNova Group Deutschland GmbH. These devices have been available since 2006.
The manufacturer advertises the device as being an efficient heating and cooling machine. In October 2016, however, in response to the FDA and CDC warnings, the company released a “field safety notice update” warning surgeons and hospitals of potential risks associated with the use of the machines.
The manufacturer acknowledged the CDC had confirmed with laboratory testing that M. chimaera found on certain 3T HCUs showed a “genetic similarity between both patient and heater cooler strains of the NTM bacteria M. chimaera isolated in Iowa and Pennsylvania.”
They added that they were “continuing to analyze” the data, would work with the CDC and the FDA to facilitate their recommendations for reducing risk, and would “develop solutions to further mitigate the potential risk of NTM contamination.”
The company has been aware of infections and even deaths linked to these devices since no later than 2010. Between January 2010 and February 2016, the FDA received 180 incident reports related to HCUs around the world. These reports include 16 U.S. hospitals across 10 states, where at least 45 patients were infected and at least nine died.
Consumer Reports noted that in 2015, Greenville Memorial Hospital in South Carolina, officials identified at least 15 patients that were diagnosed with rare infections after open heart and lung operations. Four of them died. An investigation traced the infections to the HCDs used in the operations.
Heater-Cooler Units Can be Contaminated with Bacteria
NTM organisms occur naturally in the environment and are found in water and soil. They are not usually dangerous to humans unless they’re inhaled or if they enter the body in another way, such as during surgery.
Most people who are exposed to NTM organisms don’t suffer infections, but for people with weak immune systems, or who undergo these types of surgeries, the risk of infection is greater.
In a 2016 study, researchers identified HCUs as the source of M. chimaera that caused surgical site infections in patients. Their results confirmed, “airborne transmission of M. chimaera aerosols from a contaminated HCU to an open surgical field despite ultraclean air ventilation.”
In another 2016 study, researchers found a link between M. chimaera samples taken from several European infected patients, from the HCUs used during their procedures, and from environmental samples from Sorin’s HCU production and servicing facility in Germany. Researchers concluded that at least some of the M. chimaera infections may have been caused by HCUs that were contaminated at the manufacturing site.
So far, a Seattle hospital is the only one to report a connection between HCDs (made by another manufacturer) and Legionnaire’s disease. But patient advocates warn that there may be other similar cases. Though most of the reported infections have involved M. chimaera, and M. Abscessus, another form of NTM, these devices are difficult to clean, which means they may be a source of potential contamination with other bacteria as well.
FDA Tracks Problem of Stöckert 3T Heater-Cooler Unit Infections
The FDA has been following the issue of HCU-related infections for over a year, and has taken the following actions related to these devices:
- October 2015: The FDA released a safety communication warning that the use of HCUs was associated with NTM infections, “primarily in patients undergoing cardiothoracic surgical procedures.” In some cases, patients presented with infections “several months to years after their surgical procedures.” It recommended that facilities and staff strictly adhere to cleaning and disinfection instructions, and to use only sterile water to rinse, fill, or refill the tanks.
- December 2015: The FDA issued a warning letter to the manufacturer after inspections of several of their facilities revealed significant issues, including quality system and premarket clearance violations. It also placed an import alert on the devices to restrict how many could come into the U.S.
- June 2016: The FDA released an updated safety communication warning of potential infections associated with the use of the Stöckert 3T HCU. This time, it revealed that testing by the manufacturer back in August 2014 found M. chimaera on the production line and water supply at the 3T HCU manufacturing facility. In response, in September 2014, the company added cleaning and disinfection procedures to the production line. Samples taken in June 2015 showed no bacteria contamination. The FDA recommended that facilities that purchased and used the 3T HCU prior to September 2014 be aware that the units may have been shipped from the factory contaminated with M. chimaera.
- October 2016: The FDA released another safety communication, warning that health care facilities should take additional steps to help mitigate the risk of infections associated with 3T HCUs. Specifically, it recommended that any facility with devices manufactured prior to September 2014 should “strongly consider transitioning away from the use of these devices for open-chest cardiac surgery until the manufacturer has implemented strategies for these devices to mitigate the risks of patient infection.”
- Ongoing: The FDA continues to evaluate infections associated with heater-cooler devices, primarily in patients going through open-heart surgery. It is also working to determine the cause of these infections, one of which may be the heater-cooler design.
Types of Injuries Associated with Stöckert 3T Heating-Cooling Units
Most infections show up rather quickly, but that’s often not the case with HCU-related infections. M. chimaera is a slow-growing bacterium, which means that it can be present inside a patient for months and even years without detection. The CDC warns that patients who have been exposed through open-heart surgery can “develop general and nonspecific symptoms that can often take months to develop.”
That means it’s important for doctors and patients to be on the lookout for potential symptoms. Otherwise, a diagnosis can be missed or delayed, sometimes for years. During that time, the bacteria continue to grow, so that when the infection is finally detected, it may be more difficult to treat.
So far, there is no blood test or other type of medical test to determine that a person has been exposed to the bacteria. There is a specific test that doctors can give to diagnose an M. chimaera infection. Traditionally, however, most hospitals did not perform this specific laboratory culture in the normal course of treating an infection. And if it is done, it takes months for the bacteria to grow enough for the culture to detect the infection.
Patients who have undergone open-heart surgery should notify their doctor immediately if they experience any of the following symptoms:
- Night sweats
- Muscle aches
- Weight loss
- Unexplained fever
- Difficulty breathing
- Persistent cough or cough with blood
Other infection-related complications that can occur up to years after surgery include:
- Surgical site infection
- Endocarditis (inflammation of the inner lining of the heart)
- Bacteremia (bacteria in the blood)
- Osteomyelitis (inflammation in the bone)
We’ve put together this timeline to highlight the potential link between 3T heater-cooler devices and nontuberculous mycobacterium infections:
Use the arrows on the left and right side of the timeline slideshow to navigate through its progression.
Stöckert 3T Heater-Cooler Unit Lawsuits
In February 2016, two York County, Pennsylvania residents who had heart surgery at WellSpan York Hospital filed a new multimillion-dollar federal class-action lawsuit in Pennsylvania. They named as defendant the manufacturer of the Stöckert 3T HCU devices used in their surgeries.
The plaintiffs filed the lawsuit after receiving a letter from the hospital alerting them that they may have been exposed to NTM bacteria during their surgeries. They seek damages on behalf of themselves and other patients who were exposed. In their complaint, they allege that eight people who had open-heart surgery at WellSpan were diagnosed with NTM infections, five of which had died. According to their complaint, the CDC has linked the infections to the Stöckert 3T HCU.
If you or a loved one had a cardiothoracic surgery in which a Stöckert 3T HCU was used and then developed a serious infection, you may be eligible to file a Stöckert 3T HCU lawsuit.
Patients may be unaware of which device was used in their surgery. If you or your loved one was informed that you may have been exposed to a dangerous bacteria in open-heart surgery, Chaffin Luhana provides consultations and case evaluations to help determine which device was used and whether you may have a case to recover for your potential Stöckert 3T HCU injuries.
Call today for a free and confidential case evaluation at 1-888-316-2311. Chaffin Luhana Pittsburgh attorneys represent individuals in West Virginia, Western Pennsylvania, and Eastern Ohio.